Opevesostat

Phase 3Small molecule

Merck & Co.

Opevesostat is one of 70 small molecule programs targeting Malignant Neoplasm. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Malignant NeoplasmRecruiting

Prostate Cancer MetastaticRecruiting

Castration Resistant Prostatic CancerRecruiting

Prostatic Neoplasms, Castration-ResistantRecruiting

Prostate CancerActive, not recruiting

Malignant NeoplasmPhase 2

Recruiting

Prostate Cancer MetastaticPhase 3

Recruiting

Castration Resistant Prostatic CancerPreclinical

Recruiting

Prostatic Neoplasms, Castration-ResistantPreclinical

Recruiting

Prostate CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Phase 3

20 2

Cabometyx

Bristol-Myers Squibb

Phase 3

12 3

Glucophage

EMD Serono

Phase 3

14 4

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

10 5

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

7 6

Lutetium Lu-177 PNT2002

JJonsson Comprehensive Cancer Center

Phase 3

4 7

Opevesostat

Merck & Co.

Phase 3

2 8

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 9

HC-1119

HHinova Pharmaceuticals Inc.

Phase 3

2 10

Trexall

Jazz Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Malignant Neoplasm

NCT06979596

Q1 2029

PreclinicalRecruiting

Prostatic Neoplasms, Castration-Resistant

NCT06353386

Q1 2030

Phase 3Recruiting

Prostate Cancer Metastatic

NCT06136624

Q4 2030

Phase 3Recruiting

Metastatic Castration-Resistant Prostate Cancer, Mcrpc

NCT06136650

Clinical

Trials by Indication[1]

Prostate Cancer2 trials

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06136598·14 enrolled

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06104449·6 enrolled

Absorption1 trial

A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06566989·8 enrolled

Interaction1 trial

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06633419·14 enrolled

Moderate Hepatic Impairment1 trial

A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06860243·16 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136650·1,314 enrolled

5 more indications

Castration Resistant Prostatic Cancer1 trial

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06863272·360 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06353386·220 enrolled

Prostate Cancer Metastatic1 trial

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136624·1,310 enrolled

Malignant Neoplasm1 trial

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06979596·250 enrolled

Unspecified1 trial

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07548606·14 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Opevesostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Opevesostat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Opevesostat. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Opevesostat

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2029

Q1 2030

Q4 2030

Trials by Indication[1]

Prostate Cancer2 trials

Absorption1 trial

Interaction1 trial

Moderate Hepatic Impairment1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Castration Resistant Prostatic Cancer1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

Prostate Cancer Metastatic1 trial

Malignant Neoplasm1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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